The American Society for Microbiology (ASM) appreciates the opportunity to review and comment on the proposed National Correct Coding Initiative Medically Unlikely Edits (MUEs), Phase IV. The ASM is the largest, single life sciences Society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents approximately 42,000 microbiologists, including scientists and science administrators working in a variety of areas, including biomedical, environmental, and clinical microbiology.

Many of our members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology or immunology laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating the performance of new technologies. Thus, our Society has a significant interest in correct coding for laboratory testing to ensure reasonable reimbursement for medically necessary laboratory testing for Medicare beneficiaries.

The ASM appreciates the need to perform systematic post-claim reviews to identify aberrant utilization patterns including the establishment of MUE’s to detect over utilization or utilization that is incompatible with anatomic considerations, CPT code descriptors or coding instructions, the nature of an analyte, the nature of a procedure or service, or the nature of equipment. In addition, we appreciate that medical standards of care must be considered in developing MUE’s. For the Phase IV MUE’s, we have concerns with several CPT codes for infectious disease serology testing. As requested, our recommendations and supporting information are attached in a separate document, and reiterate our previous concerns that (1) serologic testing for a single named analyte may detect more than one class of antibody (e.g. IgG and/or IgM), (2) analysis may require simultaneous testing of paired sera for each analyte (acute and convalescent, with different collection dates but possibly the same retrieval date), and (3) a single named analyte in a descriptor may in fact, include several antigenically distinct infectious agents.

As we move forward in the MUE process, these concerns will be similarly stated for many other CPT codes which are appropriately used more than one time for a single date of service due to analyte heterogeneity.

The ASM appreciates the opportunity to review the Phase IV proposed MUE edits and make recommendations prior to the October 1, 2007 implementation date. We support the goal of the Centers for Medicare and Medicaid Services and its contractors to provide medically necessary and clinically appropriate laboratory testing to Medicare Part B beneficiaries through the process of correct coding and judicious utilization. However, we are also dedicated to ensuring that claims review programs not be established which could inappropriately restrict the ability of ordering providers to obtain medically necessary diagnostic information, the ability of beneficiaries to receive the benefit of such laboratory testing, or the ability of the laboratory to receive appropriate reimbursement for services performed.

Please let us know if we can provide any additional information to further assist you or to clarify our concerns and recommendations.